The Complementary Therapies for Labour and Birth Study making sense of labour and birth - Experiences of women, partners and midwives of a complementary medicine antenatal education course.

OBJECTIVE: to gain insight into the experiences of women, partners and midwives who participated in the Complementary Therapies for Labour and Birth Study, an evidence based complementary medicine (CM) antenatal education course. DESIGN: qualitative in-depth interviews and a focus group as part of the Complementary Therapies for Labour and Birth Study. SETTING AND PARTICIPANTS: thirteen low risk primiparous women and seven partners who had participated in the study group of a randomised controlled trial of the complementary therapies for labour and birth study, and 12 midwives caring for these women. The trial was conducted at two public hospitals, and through the Western Sydney University in Sydney, Australia. INTERVENTIONS: the Complementary Therapies for Labour and Birth (CTLB) protocol, based on the She Births® course and the Acupressure for labour and birth protocol, incorporated six evidence-based complementary medicine (CM) techniques; acupressure, relaxation, visualisation, breathing, massage, yoga techniques and incorporated facilitated partner support. Randomisation to the trial occurred at 24-36 weeks' gestation, and participants attended a two-day antenatal education programme, plus standard care, or standard care alone. FINDINGS: the overarching theme identified in the qualitative data was making sense of labour and birth. Women used information about normal birth physiology from the course to make sense of labour, and to utilise the CM techniques to support normal birth and reduce interventions in labour. Women's, partners' and midwives' experience of the course and its use during birth gave rise to supporting themes such as: working for normal; having a toolkit; and finding what works. KEY CONCLUSIONS: the Complementary Therapies for Labour and Birth Study provided women and their partners with knowledge to understand the physiology of normal labour and birth and enabled them to use evidence-based CM tools to support birth and reduce interventions. IMPLICATIONS FOR PRACTICE: the Complementary Therapies for Labour and Birth Study introduces concepts of what constitutes normal birth and provides skills to support women, partners and midwives. It appears to be an effective form of antenatal education that supports normal birth, and maternity services need to consider how they can reform current antenatal education in line with this evidence.

Complementary therapies for labour and birth study: a randomised controlled trial of antenatal integrative medicine for pain management in labour.

OBJECTIVE: To evaluate the effect of an antenatal integrative medicine education programme in addition to usual care for nulliparous women on intrapartum epidural use. DESIGN: Open-label, assessor blind, randomised controlled trial. SETTING: 2 public hospitals in Sydney, Australia. POPULATION: 176 nulliparous women with low-risk pregnancies, attending hospital-based antenatal clinics. METHODS AND INTERVENTION: The Complementary Therapies for Labour and Birth protocol, based on the She Births and acupressure for labour and birth courses, incorporated 6 evidence-based complementary medicine techniques: acupressure, visualisation and relaxation, breathing, massage, yoga techniques, and facilitated partner support. Randomisation occurred at 24-36 weeks' gestation, and participants attended a 2-day antenatal education programme plus standard care, or standard care alone. MAIN OUTCOME MEASURES: Rate of analgesic epidural use. Secondary: onset of labour, augmentation, mode of birth, newborn outcomes. RESULTS: There was a significant difference in epidural use between the 2 groups: study group (23.9%) standard care (68.7%; risk ratio (RR) 0.37 (95% CI 0.25 to 0.55), p≤0.001). The study group participants reported a reduced rate of augmentation (RR=0.54 (95% CI 0.38 to 0.77), p<0.0001); caesarean section (RR=0.52 (95% CI 0.31 to 0.87), p=0.017); length of second stage (mean difference=-0.32 (95% CI -0.64 to 0.002), p=0.05); any perineal trauma (0.88 (95% CI 0.78 to 0.98), p=0.02) and resuscitation of the newborn (RR=0.47 (95% CI 0.25 to 0.87), p≤0.015). There were no statistically significant differences found in spontaneous onset of labour, pethidine use, rate of postpartum haemorrhage, major perineal trauma (third and fourth degree tears/episiotomy), or admission to special care nursery/neonatal intensive care unit (p=0.25). CONCLUSIONS: The Complementary Therapies for Labour and Birth study protocol significantly reduced epidural use and caesarean section. This study provides evidence for integrative medicine as an effective adjunct to antenatal education, and contributes to the body of best practice evidence. TRIAL REGISTRATION NUMBER: ACTRN12611001126909.

Diabetes Mellitus, Cognitive Impairment, and Traditional Chinese Medicine.

Diabetes mellitus (DM) is a metabolic disorder affecting a large number of people worldwide. Numerous studies have demonstrated that DM can cause damage to multiple systems, leading to complications such as heart disease, cancer, and cerebrovascular disorders. Numerous epidemiological studies have shown that DM is closely associated with dementia and cognition dysfunction, with recent research focusing on the role of DM-mediated cerebrovascular damage in dementia. Despite the therapeutic benefits of antidiabetic agents for the treatment of DM-mediated cognitive dysfunction, most of these pharmaceutical agents are associated with various undesirable side-effects and their long-term benefits are therefore in doubt. Early evidence exists to support the use of traditional Chinese medicine (TCM) interventions, which tend to have minimal toxicity and side-effects. More importantly, these TCM interventions appear to offer significant effects in reducing DM-related complications beyond blood glucose control. However, more research is needed to further validate these claims and to explore their relevant mechanisms of action. The aims of this paper are (1) to provide an updated overview on the association between DM and cognitive dysfunction and (2) to review the scientific evidence underpinning the use of TCM interventions for the treatment and prevention of DM-induced cognitive dysfunction and dementia.

Choosing chemical markers for quality assurance of complex herbal medicines: Development and application of the herb MaRS criteria.

With increasing use of herbal medicines for chronic or serious illness, relevant quality assurance methods are essential for making claims of therapeutic benefit. Adequate demonstration of safety and efficacy based on chemical composition and ensuring consistency between manufactured batches is critical. To date, there has been no uniform standard approach or detailed framework provided to industry for selecting relevant chemical markers used to standardize herbal products. We developed the Herbal Marker Ranking System (Herb MaRS) providing guidance on prioritizing the selection of chemical markers for quality control of complex multi-herb mixtures, while also taking into account the bioactivity in relation to the symptoms of the disease and its concentration in the formula. We apply the Herb MaRS evaluation criteria to a seven-herb formulation for the treatment of irritable bowel syndrome with constipation. Our ranking scale accommodates the clinical and pharmacological use of the formulation and its claimed indications.

Acupuncture and acupressure for pain management in labour and birth: a critical narrative review of current systematic review evidence.

BACKGROUND: Reviews of maternity services highlight the need for a reduction of medical interventions for women with low risk pregnancies and births to prevent the potential cascade of interventions and their associated risks. Complementary medicines (CM) such as acupuncture and acupressure have claimed to be effective in reducing interventions in labour; however, systematic reviews of evidence to date are conflicting. AIMS: To examine current evidence from systematic reviews on the topic of acupuncture and acupressure for pain management in labour and birth, and to evaluate the methodological and treatment frameworks applied to this evidence. METHODS: A search limited to systematic reviews of the MEDLINE, CINAHL, PUBMED, EMBASE and Cochrane databases was performed in December 2013 using the keywords 'CAM', 'alternative medicine', 'complementary medicine', 'complementary therapies', 'traditional medicine', 'Chinese Medicine', 'Traditional Chinese Medicine', 'acupuncture', 'acupressure', cross-referenced with 'childbirth', 'birth', labo*r', and 'delivery'. The quality of the evidence is also evaluated in the context of study design. RESULTS: The RCTs included in these systematic reviews differed in terms of study designs, research questions, treatment protocols and outcome measures, and yielded some conflicting results. It may be inappropriate to include these together in a systematic review, or pooled analysis, of acupuncture for labour with an expectation of an overall conclusion for efficacy. Trials of acupuncture and acupressure in labour show promise, but further studies are required. CONCLUSION: The use of current systematic reviews of the evidence for acupuncture and acupressure for labour and birth may be misleading. Appropriate methods and outcome measures for investigation of acupuncture and acupressure treatment should more carefully reflect the research question being asked. The use of pragmatic trials designs with woman-centred outcomes may be appropriate for evaluating the effectiveness of these therapies.

Defining research priorities in complementary medicine in oncology.

OBJECTIVES: The high usage of complementary and alternative medicines (CAM) by cancer patients is increasing, despite limited research available to support their use. Therefore identifying research priorities that can inform the evidence base for CAM treatment is relevant for many stakeholders, including funders, researchers and consumers. DESIGN AND SETTING: Integrative medicine experts, oncologists with interest in CAM research, consumer representatives and CAM practitioners and researchers took part in a modified Delphi process conducted online over three rounds. In round 1 each participant recommended up to five CAM research priorities, which were collated and ranked in round 2 by their potential usefulness in cancer care, using a Likert scale. In round 3, participants ranked the remaining propositions by their ability to impact cancer care in Australia. The lowest ranking priorities were eliminated at the completion of each round. RESULTS: From the 122 propositions originally submitted by the 27 participants, the highest scoring ones included: studying interactions between biologically based CAM and conventional cancer treatments, examining CAM effects on quality of life, identifying effective communication strategies around CAM, studying the role of physical activity in symptom relief and cancer prevention and exploring the role of acupuncture in cancer care. CONCLUSION: This method of research prioritisation achieved consensus of opinion among a very diverse group of stakeholders, invited to collaborate around a highly polarising topic. Through a structured interaction, the group agreed on a priority research list acceptable to all stakeholders, which can serve as a blueprint for CAM research in oncology in Australia.

Use of complementary therapies by Australian women with breast cancer.

International research suggests complementary therapy usage is common in women with breast cancer. Comparable data do not exist for Australia. A self-completed questionnaire was used to survey Australian women with breast cancer about their usage of complementary therapies. The survey was mailed to members of two breast cancer consumer advocacy groups, and assessed type of therapy used, reasons for use, and sources of information about complementary therapies. Of 367 respondents with breast cancer, 87.5% had used complementary therapies, with many using four or more therapies. Most commonly used were vitamin supplements (54.2%), support groups (49.8%), massage (41.4%) and meditation (38.7%). Common reasons for use included improving physical (86.3%) and emotional (83.2%) wellbeing and boosting the immune system (68.8%). Women sought information about complementary therapies from a variety of sources. The range of therapies used and the diverse reasons for use emphasise the need for reliable, evidence-based information about complementary therapies for women and clinicians.

Chinese herbal medicine for primary dysmenorrhoea.

BACKGROUND: Conventional treatment for primary dysmenorrhoea has a failure rate of 20% to 25% and may be contraindicated or not tolerated by some women. Chinese herbal medicine may be a suitable alternative. OBJECTIVES: To determine the efficacy and safety of Chinese herbal medicine for primary dysmenorrhoea when compared with placebo, no treatment, and other treatment. SEARCH STRATEGY: The Cochrane Menstrual Disorders and Subfertility Group Trials Register (to 2006), MEDLINE (1950 to January 2007), EMBASE (1980 to January 2007), CINAHL (1982 to January 2007), AMED (1985 to January 2007), CENTRAL (The Cochrane Library issue 4, 2006), China National Knowledge Infrastructure (CNKI, 1990 to January 2007), Traditional Chinese Medicine Database System (TCMDS, 1990 to December 2006), and the Chinese BioMedicine Database (CBM, 1990 to December 2006) were searched. Citation lists of included trials were also reviewed. SELECTION CRITERIA: Any randomised controlled trials involving Chinese herbal medicine versus placebo, no treatment, conventional therapy, heat compression, another type of Chinese herbal medicine, acupuncture or massage. Exclusion criteria were identifiable pelvic pathology and dysmenorrhoea resulting from the use of an intra-uterine contraceptive device. DATA COLLECTION AND ANALYSIS: Quality assessment, data extraction and data translation were performed independently by two review authors. Attempts were made to contact study authors for additional information and data. Data were combined for meta-analysis using either Peto odds ratios or relative risk (RR) for dichotomous data or weighted mean difference for continuous data. A fixed-effect statistical model was used, where suitable. If data were not suitable for meta-analysis, any available data from the trial were extracted and presented as descriptive data. MAIN RESULTS: Thirty-nine randomised controlled trials involving a total of 3475 women were included in the review. A number of the trials were of small sample size and poor methodological quality. Results for Chinese herbal medicine compared to placebo were unclear as data could not be combined (3 RCTs). Chinese herbal medicine resulted in significant improvements in pain relief (14 RCTs; RR 1.99, 95% CI 1.52 to 2.60), overall symptoms (6 RCTs; RR 2.17, 95% CI 1.73 to 2.73) and use of additional medication (2 RCTs; RR 1.58, 95% CI 1.30 to 1.93) when compared to use of pharmaceutical drugs. Self-designed Chinese herbal formulae resulted in significant improvements in pain relief (18 RCTs; RR 2.06, 95% CI 1.80 to 2.36), overall symptoms (14 RCTs; RR 1.99, 95% CI 1.65 to 2.40) and use of additional medication (5 RCTs; RR 1.58, 95% CI 1.34 to 1.87) after up to three months of follow-up when compared to commonly used Chinese herbal health products. Chinese herbal medicine also resulted in better pain relief than acupuncture (2 RCTs; RR 1.75, 95% CI 1.09 to 2.82) and heat compression (1 RCT; RR 2.08, 95% CI 2.06 to 499.18). AUTHORS' CONCLUSIONS: The review found promising evidence supporting the use of Chinese herbal medicine for primary dysmenorrhoea; however, results are limited by the poor methodological quality of the included trials.

The determination of glycyrrhizic acid in Glycyrrhiza uralensis Fisch. ex DC. (Zhi Gan Cao) root and the dried aqueous extract by LC-DAD.

A rapid, sensitive and specific reversed phase high-performance liquid chromatographic (LC) method with photodiode array detection (DAD) has been developed for the determination of glycyrrhizic acid in both the raw herb and a commercially prepared dried aqueous extract of Glycyrrhiza uralensis Fisch. ex DC. root (Zhi Gan Cao, liquorice). It was determined that extracting the raw herb in aqueous methanol (50:50 v/v) by sonication for 2 x 30 min was the most efficient sample preparation. Baseline resolution of the glycyrrhizic acid peak was achieved on a Varian Polaris RP C18-A (250 mm x 4.6 mm, 5 microm packing) column using an isocratic mobile phase consisting of 0. v aqueous phosphoric acid and acetonitrile in the ratio 60:40 v/v. Chromatograms were monitored between 200 and 400 nm for peak purity assessments, with quantitation performed at 254 nm. Glycyrrhizic acid calibration curves in the concentration range of 14-558 microg/ml were prepared on the day of analysis. Curve fitting was by the least-squares method, with correlation coefficients of >0.9998 obtained each time. The average recovery at three spike levels (50, 100, 200%) was of 95.91+/-1.05% and 98.36+/-3.45% (+/-S.D., n=7) for the spiked raw herb and dried aqueous extract respectively. The limit of detection and limit of quantitation was 0.52 and 1.72 mg/g respectively for the raw herb, and 0.75 and 2.51 mg/g respectively for the dried aqueous extract. Identity confirmation of the chromatographic peak was achieved by (-) electrospray ionisation tandem mass spectrometry. The concentration of glycyrrhizic acid in the root and dried aqueous extract was found to be 31.1+/-0.2 and 40.4+/-0.3mg/g (+/-S.D., n=7) respectively.

Chinese herbal medicine for primary dysmenorrhoea.

BACKGROUND: Conventional treatment for primary dysmenorrhoea (PD) has a failure rate of 20% to 25% and may be contraindicated or not tolerated by some women. Chinese herbal medicine (CHM) may be a suitable alternative. OBJECTIVES: To determine the efficacy and safety of CHM for PD when compared with placebo, no treatment, and other treatment. SEARCH STRATEGY: The Cochrane Menstrual Disorders and Subfertility Group Trials Register (to 2006), MEDLINE (1950 to January 2007), EMBASE (1980 to January 2007), CINAHL (1982 to January 2007), AMED (1985 to January 2007), CENTRAL (The Cochrane Library issue 4, 2006), China National Knowledge Infrastructure (CNKI, 1990 to January 2007), Traditional Chinese Medicine Database System (TCMDS, 1990 to Dec 2006), and the Chinese BioMedicine Database (CBM, 1990 to Dec 2006) were searched. Citation lists of included trials were also reviewed. SELECTION CRITERIA: Any randomised controlled trials (RCTs) involving CHM versus placebo, no treatment, conventional therapy, heat compression, another type of CHM, acupuncture or massage. Exclusion criteria were identifiable pelvic pathology and dysmenorrhoea resulting from the use of an intra-uterine contraceptive device (IUD). DATA COLLECTION AND ANALYSIS: Quality assessment, data extraction and data translation were performed independently by two review authors. Attempts were made to contact study authors for additional information and data. Data were combined for meta-analysis using either Peto odds ratios or relative risk (RR) for dichotomous data or weighted mean difference for continuous data. A fixed-effect statistical model was used, where suitable. If data were not suitable for meta-analysis, any available data from the trial were extracted and presented as descriptive data. MAIN RESULTS: Thirty-nine RCTs involving a total of 3475 women were included in the review. A number of the trials were of small sample size and poor methodological quality. Results for CHM compared to placebo were unclear as data could not be combined (3 RCTs). CHM resulted in significant improvements in pain relief (14 RCTs; RR 1.99, 95% CI 1.52 to 2.60), overall symptoms (6 RCTs; RR 2.17, 95% CI 1.73 to 2.73) and use of additional medication (2 RCTs; RR 1.58, 95% CI 1.30 to 1.93) when compared to use of pharmaceutical drugs. Self-designed CHM resulted in significant improvements in pain relief (18 RCTs; RR 2.06, 95% CI 1.80 to 2.36), overall symptoms (14 RCTs; RR 1.99, 95% CI 1.65 to 2.40) and use of additional medication (5 RCTs; RR 1.58, 95% CI 1.34 to 1.87) after up to three months follow up when compared to commonly used Chinese herbal health products. CHM also resulted in better pain relief than acupuncture (2 RCTs; RR 1.75, 95% CI 1.09 to 2.82) and heat compression (1 RCT; RR 2.08, 95% CI 2.06 to 499.18). AUTHORS' CONCLUSIONS: The review found promising evidence supporting the use of CHM for primary dysmenorrhoea; however, results are limited by the poor methodological quality of the included trials.

Validation of a method for the simultaneous determination of four schisandra lignans in the raw herb and commercial dried aqueous extracts of Schisandra chinensis (Wu Wei Zi) by RP-LC with DAD.

A rapid and specific reversed-phase high performance liquid chromatography (RP-LC) method with photodiode array detection (DAD) was developed and validated for the determination of four common schisandra lignans, schisandrin (1), schisandrol B (2), deoxyshisandrin (3) and gamma-schisandrin (4), in raw herb materials and commercial dried aqueous extracts of Schisandra chinensis (Wu Wei Zi). The extraction solvent and extraction method were optimised where it was found that a 4 h Soxhlet extraction using methanol was successful at extracting >99.5% of each of the schisandra lignans analysed from the raw herb material. The sample preparation process for the dried aqueous extract samples involved sonication using methanol for 2 x 30 min. The herb and extract solutions were separated on a Varian Microsorb-MV 100-5 C18 column using a gradient mixture of 0.1% aqueous phosphoric acid and acetonitrile. Subsequent detection and quantitation of the schisandra lignans was performed at 210 nm. The correlation coefficients of the linear regression analysis performed on these calibration curves were >0.9996 for all four schisandra lignans assayed. The detection limits and quantification limits ranged from 0.12 to 0.57 and 0.41 to 1.89 mg g(-1), respectively. The mean recoveries of the various analytes ranged from 92.20 to 107.01%. The method was used to investigate the levels of the four mentioned components in herb samples and dried aqueous extracts. The identities of the chromatographic peaks were confirmed by (+) electrospray ionisation LC-MS/MS.

Are national quality standards for traditional Chinese herbal medicine sufficient? Current governmental regulations for traditional Chinese herbal medicine in certain Western countries and China as the Eastern origin country.

Traditional Chinese herbal Medicine (TCHM) has been gaining interest and acceptance world wide. TCHM provides on the one side promising perspective of scientific interest and on the other side possible health risks if TCHM drugs are not controlled with respect to quality standards or if practitioners for TCHM are not well trained. This paper outlines an introduction to the scientific aspects and potential risks of TCHM therapy followed by a brief, exploratory overview of the current status of TCHM regulations in certain Western countries like the USA, United Kingdom, Germany, Australia and in China as the Eastern origin country of TCHM. Legal foundations to establish quality and safety standards for TCHM crude drugs and ready-made formulas exist in some countries on a local basis but in practice are poorly enforced, where this products have no drug status. In addition practitioners treating patients with TCHM should be well versed in the pharmacology, side effects, and interactions of these substances with Western medicines and should be certified on a regular basis.

Naturopathic and Western herbal medicine practice in Australia-a workforce survey.

BACKGROUND: Despite substantial growth in the use of complementary medicine, no comprehensive national study has been undertaken of the naturopathic and Western herbal medicine component of the healthcare workforce in Australia. This study aimed to examine the nature of these practices and this currently unregulated workforce in Australia. METHODS: A comprehensive survey questionnaire was developed in consultation with the profession and distributed nationally to all members of the naturopathic and Western herbal medicine workforce. RESULTS: The practices of herbal medicine and naturopathy make up a sizeable component of the Australian healthcare sector, with approximately 1.9 million consultations annually and an estimated turnover of $AUD 85 million in consultations (excluding the cost of medicines). A large proportion of patients are referred to practitioners by word of mouth. Up to one third of practitioners work in multidisciplinary clinics with other registered sectors of the healthcare community. The number of adverse events associated with herbal medicines, nutritional substances and homoeopathic medicines recorded in Australia is substantial and the types of events reported are not trivial. Data suggest that practitioners will experience one adverse event every 11 months of full-time practice, with 2.3 adverse events for every 1000 consultations (excluding mild gastrointestinal effects). CONCLUSION: These data confirm the considerable degree of utilisation of naturopathic and Western herbal medicine practitioners by the Australian public. However, there is a need to examine whether statutory regulation of practitioners of naturopathy and Western herbal medicine is required to better protect the public.

The association of anorectal leiomyomatosis and diffuse oesophageal leiomyomatosis.

Anorectal leiomyomatosis is exceedingly rare in children. Its association with the more common diffuse oesophageal leiomyomatosis has been documented in only two previous cases. This report describes the presentation, diagnosis and treatment of two further cases of diffuse oesophageal combined with anorectal leiomyomatosis.

Gastrointestinal duplications.

BACKGROUND/PURPOSE: The aim of this study was to review the presentations of gastrointestinal duplication (GID) and to assess the influence of prenatal diagnosis on treatment. METHODS: Retrospective review of all GID at 2 pediatric hospitals from 1980-2002 was conducted. RESULTS: Seventy-three patients (M43:F30) were identified: 21 neonates, 28 infants (1 to 24 months), 15 children (1 to 10 years), 9 adolescents (>/=11 years). GID location by frequency was ileum (31.5%), ileocaecal valve (30.2%), duodenum (9.6%), stomach (8.2%), jejunum (8.2%), colon (6.8%), and rectum (5.5%). In neonates and infants, vomiting and distension were the most common presentations. Volvulus, caused by a duplication, occurred in 23.8% of neonates and caused the death of one neonate. Intussusception was identified in 10.9% of patients. In older children and adolescents, pain and vomiting were the most common associations. Six of these patients were being treated for Crohn's disease, with the diagnosis of duplication made at laparotomy. Eighteen patients had a prenatal diagnosis by ultrasound scan, with 77.2% of these asymptomatic after birth. Most prenatal diagnoses occurred after 1991 (77.8%). When comparing an earlier period (1980 to 1991; 29 patients) with the current (1992 to 2002; 44 patients), a greater proportion of the latter patients were asymptomatic (36.4 v 13.8%) and had a lower incidence of complications (volvulus/intussusception). CONCLUSIONS: GID can lead to life-threatening complications. Prenatal diagnosis should lead to expeditious postnatal investigation and treatment before the onset of symptoms or complications. GID in older children can mimic Crohn's disease. Laparoscopy/laparotomy should be considered in patients with atypical Crohn's disease or when the diagnosis of an intraabdominal mass is unclear.

Regulation of complementary medicine practitioners in Australia: Chinese medicine as a case example.

Complementary and alternative medicine (CAM) forms a significant part of the health economy. CAM practices are under increased scrutiny from consumers, clinicians, scientists and regulators. Australian authorities have explored a range of regulatory approaches. This paper outlines initiatives to regulate the practice of CAM in Australia and examines relevant issues with a particular focus on the registration of Chinese medicine practitioners in the State of Victoria.

Surgical resection and chemotherapy improve survival rate for patients with hepatoblastoma.

BACKGROUND: The authors reviewed retrospectively their experience in 30 children with hepatoblastoma (HB). Despite an increased trend in the incidence of HB during the last 2 decades, an encouraging cure rate has been achieved with complete resection of the tumor and chemotherapy before or after surgery with cisplatin plus doxorubicin (Adriamycin) or cisplatin plus vincristine plus 5-Fluorouracil. RESULTS: There were 10 female and 20 male patients. For the period from 1963 to 1980 there were 8 patients, and for the period from 1981 to 1998 there were 22 patients. Their mean age at surgery was 16 months (range, 3.5 months to 5.5 years). Tumors were localized to the right lobe in 10 (42%), to the left lobe in 7 (29%), and in both lobes in 7 (29%) of the resected patients. Tumors were greater than 10 cm in size in 16 (67%) of these patients. Twenty-four patients (80%), underwent liver resection before or after chemotherapy. One patient (3%) with an unresectable tumor received chemotherapy and a liver transplant. In 5 patients (17%) the hepatic involvement was too extensive for resection. The types of resection performed were right lobectomy in 7, left lobectomy in 6, right trisegmentectomy in 8, left trisegmentectomy in 2, and middle hepatectomy in 1. The overall survival rate for 35 years of the study was 60% (18 of 30). With the association of surgery and chemotherapy (1981 through 1998) survival rate is 82% (14 of 17). Overall median follow-up in our study is 8 years (range, 2.5 to 24 years). CONCLUSIONS: There has been a dramatic improvement in the results of treatment of hepatoblastoma. Formerly, only 25% to 30% of patients were cured, whereas today, with combination of chemotherapy and surgery, 75% to 80% may be cured.

Application of the general health status questionnaire SF36 to patients with gastrointestinal dysfunction: initial validation and validation as a measure of change.

OBJECTIVE: To determine whether the Short Form (SF36) Health Status Survey is a valid measure of health status and health change for patients with irritable bowel syndrome (IBS). METHODS: The SF36 was self-administered by 116 patients with IBS at the commencement and end of a controlled clinical trial. Patients were recruited through two Sydney teaching hospitals and through private gastroenterologists during 1997 and treated with Chinese herbal medicine. RESULTS: The SF36 health concepts demonstrated internal consistency, construct validity and concurrent validity when applied to patients with significant bowel dysfunction. Patient scores on two health scales of the SF36 (bodily pain, general health) correlated significantly with the bowel symptom scores recorded by patients and gastroenterologists at the beginning and end of the trial period. Actively treated patients significantly improved their scores in four out of eight of the health scales of the SF36 and reported overall improvement compared with inactively treated patients. CONCLUSIONS: The SF36 is a valid measure of general health status in IBS patients, is sensitive to the presence of IBS, and is adequately sensitive to gastrointestinal change in IBS patients. IMPLICATIONS: While the SF36 general health measure is used by the Australian Bureau of Statistics and widely overseas, until recently no data have been available on the sensitivity of the SF36 to gastrointestinal dysfunction or numerous other disorders. The SF36 is not only sensitive to the presence of IBS, it also provides a useful adjunct to current methods of evaluating treatment outcomes for IBS, and potentially other disorders.

Establishing evidence for Chinese medicine: a case example of irritable bowel syndrome.

Traditional Chinese medicine (TCM) is now used by a broad cross-section of the western community. It offers some attraction because it provides new options for treatment, an individualized approach, and potentially avoidance of harsh drugs or surgery. However, despite this growing popularity there is debate as to its evidence base. Few TCM trials have been performed in the West, and previous Chinese TCM trials have been perceived to lack methodological rigour. Establishing and applying stronger clinical trial methodologies in TCM is imperative for its integration with modern medicine and achieving the end goal of creating options for patient care. A clinical trial was designed using a variety of approaches to promote methodological rigour whilst allowing the flexibility required in TCM practice. Irritable bowel syndrome (IBS) was selected as the disease focus, creating the possibility of tailoring TCM treatments to the variable clinical presentations of IBS. Patients were randomised to receive individually tailored treatment (n = 38), a standard Chinese herbal formulation (n = 43), or placebo (n = 35) for 16 weeks. Patients, gastroenterologists and herbalists were all blinded as to treatment group. Both standard and individualized treatments were significantly more effective than the placebo treatment on all key outcome measures. However, this study failed to confirm the added value of tailoring treatments. Chinese herbal formulations individually tailored to the patient proved no more effective than the standard treatment on all measures. Nevertheless, the trial demonstrates it is possible to test individualization of treatment whilst adhering to conventional trial protocols. Clinical trials can be designed that accommodate nuances of TCM practice. This study also shows Chinese herbal medicine may offer assistance to some patients with IBS and may prove as effective as current pharmaceutical approaches. Further validation of TCM interventions is required.